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Study aim
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Evaluation of the degree of dysmenorrhea of patients with endometriosis before and after treatment with sildenafil compared to placebo;
Excessive Intake of analgesia in Endometriosis Dysmenorrhea treated with Sildenafil compared to placebo
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Design
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Pragmatic, community based, parallel group, double blind, randomized controlled trial.The study population of 40 patients suffering from endometriosis disorder is classified into two groups according to the Randomization table.
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Settings and conduct
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The setting is Arash Women's Hospital . Oral sildenafil at the dose of 100mg and placebo are given to the patients of two groups daily in the first three days of the cycle, and the degree of change in pain is compared between two groups.
To hide the random allocation process, 40 cards containing the name of treatments will be prepared. Then the cards will be placed inside sealed envelopes and the methodologist will give the drug to the patients accordingly. Surgeon, patient, person who assesses the consequences and analyzer the data are blind to the treatment provided to each patient.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: patients with moderate to severe endometriosis dysmenorrhea.
Exclusion criteria: people who take Nitrogelycerin or any hormonal therapy, people with high or low blood pressure, PID, ovarian cyst, non-cyclic pelvic pain, malignancy, acute coronary syndrom and acute ocular problem
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Intervention groups
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Intervention group: oral sildenafil 100mg was administered daily from the first day to the third day of the menstrual period. Control group: Placebo was administered in this group.
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Main outcome variables
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Primary outcome: The dysmenorrhea change rate
Secondary outcome: The amount of pain killer use during the study